FDA: No Surprises Planned for E-Cigarette Regs

When the FDA finally issues its proposed regulations on electronic cigarettes, which may be as soon as the end of the month, what will they look like? Probably pretty familiar, experts said.

The first step is likely to be just bringing the nicotine-vapor devices officially under the agency's tobacco control authority and up to speed with the age, marketing, and packaging restrictions that have long been in place for conventional cigarettes.

"Right now it's kind of the Wild West," said Peter G. Shields, MD, a cancer prevention expert at Ohio State University in Columbus. "As every day goes by without regulation, we have more of an issue with people using and liking a product [that is] potentially causing harm."

While the agency has been putting the issue on its agenda for years, a proposed rule has now been sent to the federal Office of Management and Budget (OMB).

The due date had been set for the end of October, although an FDA press officer noted that the OMB review had to wait until the partial government shutdown ended.

That delay is just the latest in a heavily criticized wait for even deeming regulations that will officially declare e-cigarettes under the FDA's purview through the 2009 federal Tobacco Control Act.

"Right now it's falling into some sort of no man's land," explained food and drug lawyer Brian J. Malkin of Frommer Lawrence & Haug in Washington.

"It's not really a drug device; it really should be a tobacco product, but FDA has not issued any sort of regulations on it yet ... anyone can just order them online. There might be age restriction in some stores but that would be by their own internal procedures," he explained.

That hasn't been the question in the U.S. The FDA announced in 2011 that it would give up its bid for tight control after a federal appeals court ruled the products only fit under the agency's authority to regulate tobacco as long as no health claims are made.

Forecast for Regulations

Other than the revelation that e-cigarettes will be classed as tobacco products, regulators have been "remarkably quiet" on their intentions, gathering input in meetings with e-cigarette makers and others, but not articulating their own thinking on the matter, noted David B. Clissold, a food and drug lawyer at Hyman, Phelps & McNamara in Washington.

"FDA has been very consistent in that they think e-cigarettes should be regulated, but the $64,000 question is how is the FDA going to do that," he told MedPage Today.

In all likelihood, the proposed rule will mainly wrap e-cigarettes under the same restrictions as other tobacco products, Malkin suggested.

That first step banning sales or marketing to minors is critical because e-cigarettes are being aggressively sold to kids through youth-oriented marketing and flavors, according to Stanton Glantz, PhD, director of the University of California San Francisco's Center for Tobacco Control Research and Education.

Flavored tobacco accounted for fully 40% of middle and high school smoking, based on data from the school-based National Youth Tobacco Survey study. The study, released by the CDC last week in the Journal of Adolescent Health, linked "flavored little cigar" use (another unregulated product) to a higher rate of having no intention to quit. Little cigars are comparable to cigarettes in terms of shape, filters, and packaging, but are marketed as a low cost alternative to cigarettes.

"Flavored tobacco products aimed at kids are a tried and true tobacco industry tactic," Paul Billings, of the American Lung Association said in a statement that called on the FDA to act on the study's findings.

Some self-regulation has been happening in the absence of federal regulation, but "as with any industry, there are people that have different standards," explained Miguel Martin, former general manager of cigarette maker Altria and now president of LOGIC Technology Development, one of the largest U.S. e-cigarette companies.

Industry appears largely to welcome the FDA's proposed rule in that it will level the playing field.

"Since the rules apply to everybody, that is a fair and equitable environment in which to conduct business," Martin said. "An environment where the FDA does regulate the sale and marketing of products is a good thing."

Once regulated, "[e-cigarette companies] are going to have to follow things like registration, product listing, ingredient listing, good manufacturing requirements, there'll be the user fees, adulteration and misbranding provisions will fall into place ... FDA can come in and inspect facilities," Malkin noted. "It's a big change from what they have now."

Wild Cards

It's less clear if the FDA's initial proposed rule will address kid-appealing flavors like bubblegum and watermelon or where sales would be allowed.

Internet sales ought to be limited because of the difficulty of age verification, suggested John Wiesehan Jr., CEO of Ballantyne Brands, which makes Mistic brand e-cigarettes.

Another possible feature would be a requirement for standardization.

Currently, there's no requirement for labeling or standards for the devices or liquids they convert to vapor, noted David B. Abrams, PhD, of the anti-tobacco American Legacy Foundation's Institute for Tobacco Research and Policy Studies in Washington.

"Liquids contain varying amounts of nicotine or none at all," he told MedPage Today. "A liquid may have additives, flavors, and contaminants in it to varying degrees, albeit at very low levels when compared with burning the tobacco as in cigarettes, hookah, and cigars."

At least some in the industry support that move, like Wiesehan, who called for testing and limits on nicotine levels.

But the FDA could have more surprises up its collective sleeve, Clissold pointed out.

"Another possible reason for the delay is maybe it's not just e-cigarettes but maybe cigars or little cigars or who know what else -- hookahs -- that FDA could decide they're going to regulate," he said, noting that those products have been stalled on the agenda even longer than e-cigarettes.

Why So Long?

The fact that it has taken more than 2 years for the government to take the next step drew the ire of some.

"They've been sitting on their hands," Glantz told MedPage Today.

Malkin was a little more forgiving, suggesting that the agency is stepping carefully as it breaks new territory in tobacco control, cautious about the possibility of unintended consequences.

"It's a public health quandary," he said.

The FDA has to increase regulatory control in a way that will maximize any benefit of e-cigarettes in supplanting tobacco, but minimize their risk of introducing new users to nicotine addiction or prolonging current smokers' habit.

However, leaving the field unregulated for so long may have backfired because it allowed the market to develop without any controls, Malkin acknowledged.

Teen and adolescent use of e-cigarettes doubled to 10% of high school students and 2.7% of middle schoolers in just one year, based on another CDC report from the National Youth Tobacco Survey.

Time Frame

Once the proposed rule does come out, the delays are still likely to add up.

First, there will be a potential 60- to 180-day period for public comment, followed by possible changes, then 6 months or a year to give companies time to comply, Clissold noted.

"We're a long way off from seeing it affect the marketplace," he told MedPage Today.

Time may be built in to allow companies to do the testing to document what is actually in their product too, Malkin added.

"With smoked tobacco products, part of what [the FDA] wanted was not just the ingredients of what you have in your product but what's inhaled," he pointed out.

Before standardization would take effect, advisory committees would have to discuss the components and evidence for harm, then come up with proposed limits, which would likely take years, he said.

And don't forget to factor in the inevitable court battle, Glantz said.

"Even if the FDA were moving aggressively, which it hasn't been on anything in tobacco, it's still going to be a long time before anything happens," he suggested. "Where I'm looking for policy interventions to protect people from e-cigarettes is the state and local governments -- to simply not allow them to be used indoors where they're polluting the air."

So far, three states -- North Dakota, New Jersey, and Utah -- have explicitly banned use of the nicotine vapor devices in smoke-free zones, and nine others have prohibited them in specific places, such as schools and state buildings.

That could be an undercount because many places enacted their smoke-free laws before the devices were widely available on the market, noted Cynthia Hallett, MPH, of the foundation based in Berkeley, Calif.

Even if it takes a few years, it's worth the wait for evidence-based federal regulations, Shields argued.

"This is really important stuff and ... if we get it wrong, we can cause harm, so another 2 or 3 years to get good data for me is worth waiting," he said.

What's the Harm?

E-cigarette advocates and skeptics alike agree that the vapor devices are a less harmful way of delivering nicotine than burning tobacco.

But whether that means e-cigarettes hold no danger remains controversial.

"There are only four ingredients in an electronic cigarette -- nicotine in different levels, flavoring, water, and propylene glycol, which is a bonding agent used in many consumer products, for example, toothpaste," Wiesehan said. "It's not the 4,000 harmful ingredients that you find in traditional tobacco."

However, a compound can have a very different health impact when eaten or put on the skin than when directly inhaled, Shields warned.

"If you're inhaling a fog that's kind of oily, are you just exhaling it or is it staying down there to cause some inflammatory process?" he questioned. "This is all theory, we don't know what's happening in people."

FDA lab tests on two e-cigarette brands back in 2009 showed that they contained carcinogens including the antifreeze ingredient diethylene glycol and nitrosamines.

The flavors and additives may be a source of low levels of particulate matter, heavy metals, and volatile organic compounds, Abrams suggested.

Cross contamination could also be happening if, for example, the devices are made in a factory that also makes car batteries, Shields added.

It made intuitive sense 30 years ago that light cigarettes were safe, but that turned out not to be true, he pointed out.

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.